ID

22957

Description

Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE); ODM derived from: https://clinicaltrials.gov/show/NCT00510952

Link

https://clinicaltrials.gov/show/NCT00510952

Keywords

  1. 6/18/17 6/18/17 -
Uploaded on

June 18, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus, Type 2 NCT00510952

Eligibility Diabetes Mellitus, Type 2 NCT00510952

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have type 2 diabetes mellitus for at least 1 year.
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1]
C0011860
are greater than or equal to 18 years old.
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have been receiving oral antihyperglycemic medications (oams), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following oams for the 6 weeks prior to visit 1: metformin-
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0025598
sulfonylureas-dipeptidyl peptidase-iv (dpp-iv) inhibitors-thiazolidinediones (tzds)
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3653359
UMLS CUI [1,3]
C1257987
have a hemoglobin a1c (hba1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before visit 2.
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0019018
body mass index (bmi) greater than or equal to 25 and less than or equal to 45 kg/meter squared.
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1]
C0557978
have taken any glucose-lowering medications not included in inclusion criterion #3; (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before visit 1.
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1]
C0087111
have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1]
C0150254
have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1,1]
C0726398
UMLS CUI [1,2]
C0019993
UMLS CUI [1,3]
C2114437
are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0009862

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00510952

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
have type 2 diabetes mellitus for at least 1 year.
boolean
C0011860 (UMLS CUI [1])
ID.2
Item
are greater than or equal to 18 years old.
boolean
C0001779 (UMLS CUI [1])
ID.3
Item
have been receiving oral antihyperglycemic medications (oams), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following oams for the 6 weeks prior to visit 1: metformin-
boolean
C0087111 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
ID.4
Item
sulfonylureas-dipeptidyl peptidase-iv (dpp-iv) inhibitors-thiazolidinediones (tzds)
boolean
C0087111 (UMLS CUI [1,1])
C3653359 (UMLS CUI [1,2])
C1257987 (UMLS CUI [1,3])
ID.5
Item
have a hemoglobin a1c (hba1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before visit 2.
boolean
C0019018 (UMLS CUI [1])
ID.6
Item
body mass index (bmi) greater than or equal to 25 and less than or equal to 45 kg/meter squared.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.7
Item
have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
boolean
C0557978 (UMLS CUI [1])
ID.8
Item
have taken any glucose-lowering medications not included in inclusion criterion #3; (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before visit 1.
boolean
C0087111 (UMLS CUI [1])
ID.9
Item
have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
boolean
C0150254 (UMLS CUI [1])
ID.10
Item
have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
boolean
C0726398 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C2114437 (UMLS CUI [1,3])
ID.11
Item
are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
boolean
C0032961 (UMLS CUI [1,1])
C0009862 (UMLS CUI [1,2])

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